Colored Suture Construction

ABSTRACT

A colored suture includes an elongate woven braid of filaments including one or more ends made of an ultra high molecular weight polyethylene (UHMWPE). The suture also includes second and third ends which can be colorable or dyeable before or after incorporation into the elongate woven braid. This invention provides surgeons with improved recognition of suture ends in surgery by construction of a bi-colored co-braid with at least two ends of different color schemes or patterns braided into a UHMWPE construction. One of the colored ends runs continuously from one end of the suture to the other end. The other colored end can be colored only on one half of the end. This provides a suture with two distinguishable ends, while still maintaining a continuous line of color along the length of the suture.

CROSS REFERENCE TO RELATED APPLICATION

This application claims priority to earlier filed U.S. ProvisionalApplication No. 61/172,989, filed on Apr. 27, 2009, the disclosure ofwhich is hereby incorporated by reference, in its entirety.

FIELD OF THE INVENTION

The present invention generally relates to a suture. More particularly,the present invention pertains to a colored construction for sutures.

BACKGROUND OF THE INVENTION

Sutures are commonly used to hold together tissue that has been severedby injury, incision, or surgery to aid in the healing process or toapply pressure to blood vessels to stop bleeding. Sutures can beabsorbable or non-absorbable. Non-absorbable sutures are made frominherently colorless materials such as silk, polypropylene, polyester,nylon, or ultra high molecular weight polyethylene (UHMWPE). Sutures arecommonly in either braided multifilament or monofilament construction,but are sometimes also known in a twisted construction. The form of asuture is usually dictated by the stiffness or fiber modulus of itsconstituent fiber. Sutures require good pliability for their handlingand knotting properties. Thus, fibers that are too stiff cannot be usedin a monofilament form for larger suture sizes but rather in bundles ofsmall denier filaments. These strands of multifilament are then braidedtogether to form a suture. As the suture diameter gets larger, a core isusually added inside the braided sheath. Fibers with a modulus belowabout 600,000 psi can be used in monofilament form, although lowermodulii are preferred. Thus, polyester and UHMWPE sutures are used inmultifilament braids, while polypropylene is used as a monofilamentsuture. Some materials like nylon 66 with borderline properties are madein both multifilament and monofilament constructions. Natural fiberslike silk that are fine denier can only be used in multifilamentconstructions.

Synthetic and most natural materials used to make sutures are withoutcolor. With the two basic constructions of braided multifilament andmonofilament many types of sutures would be indistinguishable from othersutures even though their properties might be quite different. Thus, thevalue of coloring in sutures has long been recognized. Not only doescolor provide distinction between different types of sutures but is alsoknown to aid the surgeon to keep track of sutures in the blood fieldduring surgery.

Sutures are implantable devices and only specific colorants listed inthe Code of Federal Regulations (CFR) for a particular suture materialcan be used. The regulations also put a limit on the maximum weightpercent for each colorant for each suture material. Thus, there arelimitations in colors available for all suture materials. There are alsocertain inherent limitations to how color can be added to some suturematerials based on their polymer properties and how they are processedinto sutures.

The advent of endoscopic surgery procedures has put additional pressureon surgeons to correctly identify sutures and their respective ends forproper tying of knots in confined spaces. During suturing it may benecessary for a physician to distinguish between the ends of similarsutures, which becomes more difficult when both ends of the sutures havean identical appearance of either no color or the same color.

One way to aid a surgeon in distinguishing an incoming end from anoutgoing end of a suture, is to use a “half and half” suture, in whichone half or one end is colored and the other half or end remains white.For example, Teleflex Medical of 1295 Main Street, Coventry, Conn.06238, has made a polyester braided tape since 1998 in which one half ofit has been dyed with D&C Green No. 6. So the tape has one end that isgreen and one end that is undyed white. However, a suture made fromwhite UHMWPE yarn is not dyeable owing in part to the high crystallinityof the fiber and therefore cannot be dip dyed to distinguish one sidefrom the other. To add color to a colorless braid of UHMWPE, it istherefore necessary to incorporate either a monofilament or amultifilament of a dyeable fiber material into the braided sutureconstruction. This construction can then be immersed half way into a dyebath that will only color the dyeable fiber and not the UHMWPE fiber.Although it is highly unusual to co-braid a monofilament withmultifilament yarn in a suture construction, monofilaments can be usedfor this application as they can bring a brighter color to the overallbraid.

Although the half and half does allow the surgeon to distinguish betweenthe incoming and outgoing ends of one individual suture strand, itoffers no help when two or more of the same type of suture is beingused. In these cases, there is no differentiation between the variousincoming and outgoing ends of suture from each other.

Additionally, while the ends are distinguishable in an individual halfand half suture, one half of the suture remains white and there canstill be considerable white glare observed under bright lights, such asthose used in endoscopic surgery. It is therefore also necessary toreduce the glare on the colorless portions of these sutures.

Accordingly, it is desirable to provide a UHMWPE suture which hasdistinguishable ends, a distinct junction, and has a reduced glare inthe surgical field.

SUMMARY OF THE INVENTION

The foregoing needs are met, to a great extent, by the presentinvention, wherein in some embodiments a suture that is capable ofovercoming the disadvantages described herein at least to some extent isprovided.

In accordance with an embodiment of the present invention, a sutureincludes an elongate woven braid of filaments. The elongate woven braidof filaments is made up of one or more first ends of ultra-highmolecular weight polyethylene (UHMWPE). At least one second end is madefrom a colorable material. The at least one second end is a singlecontinuous color. At least one third end is made from a dyeablematerial. The at least one third end is dyed a continuous color for aportion of its length for any one colorant.

In accordance with another embodiment of the present invention, a sutureincludes an elongate woven braid of filaments. The elongate woven braidof filaments is made up of at least a first end including ultra-highmolecular weight polyethylene (UHMWPE) multi-filament fiber and at leasta second made from a dyeable fiber material. The second end is a singlecontinuous first color. At least a third end is made from a dyeablefiber material. At least a first portion of the third end is dyed acontinuous second color. The second color can be different from thefirst color. A second portion of the third end can also be dyed acontinuous third color, different from the second color. The third colorcan also be different from the first color. A junction line between thefirst portion of the at least one third end and the second portion ofthe third end is distinct due to an application of an anti-wickingcompound during a step in formation of the suture.

In accordance with another embodiment of the present invention, the atleast one second end of the suture can be made from a fiber than can bedyed like one of nylon or polyester. The at least one third end can bemade from one of polypropylene monofilament, nylon, polyethylene, orpolyester. Additionally, the suture can include a core. One half of alength of the elongate woven braid can be dipped into a dye bath tocolor the at least one third end. Alternately, the elongate woven braidcan be dipped into a dye bath to color the third end and to etch thefirst ends comprising the ultra-high molecular weight polyethylene. Adye used to color the at least one second end can be a mordant dye andthe dye used to color the at least one third end is one of an acid, vator solvent dye. In addition, the braid can include a first color patternon a first portion of the braid and a second color pattern differentfrom the first color pattern on a second portion of the braid.

In accordance with another aspect of the present invention, a method ofmanufacture of a suture includes braiding an elongate suture from atleast a first end of ultra-high molecular weight polyethylene, at leasta second end made from a dyeable material, and at least a third end madefrom a dyeable material. The method also includes dyeing the second enda single continuous first color and dyeing at least a portion of thethird end a continuous second color. The method can also include dyeingthe second and third ends before braiding or alternately dyeing thefirst portion of the third end after the third end is braided into thesuture. A second portion of the third end of the suture can be dyed athird continuous color. Additionally, the method can include dipping atleast a half of the elongate suture into a dye bath.

There has thus been outlined, rather broadly, certain embodiments of theinvention in order that the detailed description thereof, herein may bebetter understood, and in order that the present contribution to the artmay be better appreciated. There are, of course, additional embodimentsof the invention that will be described below and which will form thesubject matter of the claims appended hereto.

In this respect, before explaining at least one embodiment of theinvention in detail, it is to be understood that the invention is notlimited in its application to the details of construction and to thearrangements of the components set forth in the following description orillustrated in the drawings. The invention is capable of embodiments inaddition to those described and of being practiced and carried out invarious ways. Also, it is to be understood that the phraseology andterminology employed herein, as well as the abstract, are for thepurpose of description and should not be regarded as limiting.

As such, those skilled in the art will appreciate that the conceptionupon which this disclosure is based may readily be utilized as a basisfor the designing of other structures, methods and systems for carryingout the several purposes of the present invention. It is important,therefore, that the claims be regarded as including such equivalentconstructions insofar as they do not depart from the spirit and scope ofthe present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a colored suture in accordance with an embodiment ofthe invention.

FIG. 2 illustrates a braided colored suture in accordance with anembodiment of the invention.

FIG. 3 schematically illustrates an in-line pattern for the coloredsuture in accordance with an embodiment of the invention.

FIG. 4 schematically illustrates a side by side pattern for the coloredsuture in accordance with an embodiment of the invention.

FIG. 5 schematically illustrates a cross pattern for the colored suturein accordance with an embodiment of the invention.

FIG. 6 illustrates a sectional view of a braided, colored suture inaccordance with an embodiment of the invention.

FIG. 7 illustrates a partially sectional view in accordance with anembodiment of the invention.

DETAILED DESCRIPTION

The present invention provides, in some embodiments, a braided, coloredsuture construction. The colored suture is an elongate woven braid offilaments including at least a first end made of an ultra high molecularweight polyethylene (UHMWPE). The suture preferably includes severalends of UHMWPE braided together. The ends of UHMWPE are a multifilamentfiber as is well known in the art. The braided, colored suture alsoincludes an end made of a material which contains a colorant which canbe either a dye or a pigment in a single continuous color, and anotherend made of a dyeable material of which at least a portion of its lengthis dyed a different color. Preferably such dyed portion of the differentcolored end constitutes only half the length of the suture. Thisinvention provides surgeons with improved recognition of suture ends insurgery by construction of a bi-colored co-braid with at least two endsof different colors braided into a UHMWPE construction. One of thecolored ends runs continuously from one end of the suture to the otherend. The other colored end is colored only on one half of the end. Thisprovides a suture with two distinguishable ends, while still maintaininga continuous line of color along the length of the suture.

The invention will now be described with reference to the drawingfigures, in which like reference numerals refer to like partsthroughout. FIG. 1 illustrates an end of a braided, colored suture 10 inaccordance with the present invention. The braided, colored suture 10has a first half 12 above axis A and a second half 14 below axis A, asshown in FIG. 1. The point where the first half 12 and the second half14 meet is a junction 16 of the braided, colored suture 10. In oneembodiment, the braided, colored suture 10 can be made from UHMWPE, amaterial that contains a continuous length of colorant, like forexample, polypropylene monofilament with the pigment[phthalocyaninato(2-)] copper and another material that is dyeable, suchas nylon or polyester. UHMWPE is generally colorless and is shown inFIG. 1 as colorless regions 18. Additionally, the first half 12 includescolored regions 20 and 22, and the second half 14 includes coloredregions 24, which match the color of region 20. These colored regions20, 22, and 24 are created by including a monofilament or multifilamentend materials containing colorants approved for use by the United StatesFood and Drug Administration (FDA).

FIG. 2 illustrates a close-up view of the second half 14 of the braided,colored suture 10, shown in FIG. 1. The braided, colored suture 10 takesthe form of an elongate woven braid of ends and has a woven appearance.The ends of the braided, colored suture 10 can be monofilaments ormultifilament ends. The ends of the continuous colored material, whichis present in both half lengths 12 and 14, are interwoven with theUHMWPE to form colored regions labeled 24. The braided, colored suture10 can be braided into different patterns depending on the placement ofthe bobbins holding the ends on the braiding machine. The possiblepatterns will be discussed further below.

The braided, colored suture 10 illustrated in FIGS. 1 and 2 can be madein one example for a USP size 2 suture by using a sixteen carrierbraider to co-braid fourteen ends of a non-colored multifilament UHMWPEyarn 18 with one end of a colored polypropylene monofilament, such as ablue polypropylene monofilament and one end of a clear monofilamentnylon. The braided, colored suture 10 is then wound on a frame and thefirst half 12 is dipped into an FDA approved color bath to color thenylon in the first half 12 to a color such as a dark green. Neither theUHMWPE nor the colored polypropylene will absorb any of the dark greendye. This results in the first half 12 of the braided, colored suture 10having colorless, blue, and dark green regions, 18, 20, and 22respectively. The second half 14 of the braided, colored suture 10 hascolorless regions 18 and 25 and blue regions 24.

Alternately, as an example of another embodiment, the braided, coloredsuture 10 illustrated in FIGS. 1 and 2 can be made by using a sixteencarrier braider to co-braid fourteen ends of UHMWPE with one end of ablack nylon monofilament that is entirely dyed with logwood extract, anFDA approved colorant, and one end of clear monofilament nylon. A woundframe of the braided, colored suture 10 is then dipped halfway into adye bath of an FDA approved colorant to color half of the end of theclear nylon. The color is not absorbed by the UHMWPE or the continuousend of black nylon that was already entirely dyed and only half of thecolorless nylon is dyed. It appears that since the logwood extract is amordant dye, it is not displaced by the dye.

Since it has been found that a dye will not affect the black color ofnylon dyed with logwood extract, this discovery can be used to preparetwo tone half and half sutures of the invention. For example, if thefirst ends are colorless UHMWPE yarn, the second end a continuous bluepolypropylene monofilament and the third end half dyed blackmonofilament nylon, then a two tone half and half suture is created whenthis braid is processed in a dye bath. The only portion of the braidthat will absorb color is the colorless half of the nylon to give a twotone half and half suture.

As illustrated in FIG. 1, the braided, colored suture 10 made in themanner described above, or made in another similar manner, will have afirst half 12 which has a color pattern that is distinguishable from acolor pattern on the second half 14. Therefore, a surgeon candistinguish a first end 26 from a second end 28 of the braided, coloredsuture 10. This prevents confusion and allows for ease and speed ofsuturing and an overall faster procedure. Having a color pattern on boththe first half 12 and the second half 14 of the braided, colored suture10 also decreases the “white glare” from intense lights used inendoscopic and other surgeries. Additionally, having a color pattern onboth the first half 12 and the second half 14 of the braided, coloredsuture 10 allows a surgeon to easily distinguish the junction 16 of thefirst half 12 of the braided, colored suture 10 and the second half 14of the braided colored suture 10. The junction 16 appears more distinct.

FIGS. 3, 4, and 5 illustrate example patterns such as in-line, side byside, and cross patterns, which are a few of the many patterns that canbe made by setting up a braiding machine in different ways. FIG. 3illustrates an in-line pattern in accordance with an embodiment of theinvention. A first half 112 of a braided colored suture 110 has apattern with two colors and each color is repeated in-line. The field118 of the suture is made from a braid of UHMWPE ends which arecolorless. A first color is represented by areas labeled 120 and asecond color is represented by areas labeled 122. The first color isincorporated by using a first co-braided end of a colored material suchas nylon or polypropylene. The second color is incorporated by using asecond co-braided end of a colorless dyeable material such as nylonwhich is subsequently dipped for a portion of the length of the suturein a dye or colorant to provide the second color. In this example, afirst half 112 of the length of the suture is dipped. The second half114 of the braided, colored suture 110 has a single colored patternrepresented by areas labeled 124, which is the result of theincorporation of the first co-braided end of colored material andmatches the color of areas 120. Because the second half 114 of thebraided, colored suture 110 is not dipped into a colorant, the otherhalf of the second co-braided end, of colorless dyeable material,remains colorless.

FIG. 4 illustrates a side by side pattern in accordance with anembodiment of the invention. A first half 212 of a braided coloredsuture 210 has a pattern with two colors side by side. The field 218 ofthe suture is made from a braid of UHMWPE ends which are colorless. Afirst color is represented by areas labeled 220 and a second color isrepresented by areas labeled 222. The first color is above the secondcolor and the two colored regions are generally parallel. The firstcolor is incorporated by using a first co-braided end of a coloredmaterial such as nylon or polypropylene. The second color isincorporated by using a second co-braided end of a colorless dyeablematerial such as nylon which is subsequently dipped for a portion of thelength of the suture in a dye or colorant to provide the second color.In this example, one half 212 of the length of the suture is dipped. Thesecond half 214 of the of the braided, colored suture 210 has a singlecolored pattern represented by areas labeled 224, which is the result ofthe incorporation of the first co-braided end of colored material andmatches the color of one of the colored areas 220 or 222. Because thesecond half 214 of the braided, colored suture 210 is not dipped into acolorant, the other half of the second co-braided end, of colorlessdyeable material, remains colorless.

FIG. 5 illustrates a cross pattern in accordance with an embodiment ofthe invention. A first half 312 of a braided colored suture 310 has apattern with two colors side by side. The field 318 of the suture ismade from a braid of UHMWPE ends which is colorless. A first color isrepresented by areas labeled 320 and a second color is represented byareas labeled 322. The first color areas are at an angle to the secondcolor areas, forming a v-shaped cross pattern. The first color isincorporated by using a first co-braided end of a colored material suchas nylon or polypropylene. The second color is incorporated by using asecond co-braided end of a colorless dyeable material such as nylonwhich is subsequently dipped for a portion of the length of the suturein a dye or colorant to provide the second color. In this example, onehalf 312 of the length of the suture is dipped. The second half 314 ofthe of the braided, colored suture 310 has a single colored patternrepresented by areas labeled 324, which is the result of theincorporation of the first co-braided end of colored material such as anylon. Because the second half 314 of the braided, colored suture 310 isnot dipped into a colorant, the other half of the second co-braided endof colorless dyeable material remains colorless.

FIGS. 6 and 7 illustrate a braided, colored suture 410 in accordancewith the present invention. The suture 410 includes monofilament ormultifilament ends made from materials such as UHMWPE, nylon, orpolyethylene. Ends 440 are made from UHMWPE and are generally colorless.End 442 is made from a monofilament or multifilament end of continuouslycolored nylon or polyethylene. End 444 is made from a monofilament ormultifilament of colorless nylon. The braided, colored suture 410 canthen be wound on a frame and half dipped into an FDA approved color bathto color half of a length of the nylon end 444 to a color such as a darkgreen. Additionally, the suture 410 can optionally include a core 446,which can take the form of a multifilament yarn, a monofilament yarn, ora braid of monofilaments or multifilament ends 447. As illustrated inFIG. 7, the end 442 made from the monofilament or multifilament end ofcontinuously colored nylon or polyethylene creates a color pattern 448on the colored braided suture 410.

In addition to, the color combinations already mentioned othercombinations might be envisioned with other approved colorants listed bythe FDA for existing suture materials. Thus, the dyes and coloredfilaments are not limited to those discussed so far. Any suitable FDAapproved colorant or colored material can be used. For example, a highdensity polyethylene monofilament colored with a blue colorant,chromium-cobalt-aluminum oxide, can also be used as the second componentcontaining continuous color. For the third component, polyester(polyethylene terephthalate (PET) or polybutylene terephthalate (PBT))could also be incorporated into the braided, colored suture andhalf-dyed.

It is also possible that existing colorants and dyes already approved incolors for one material will eventually be approved for other materials.For example, for the second component, continuous monofilaments ofpolypropylene monofilament might be colored with D&C Green #6 or D&CViolet #2. For the third component, a multifilament poly-L-lactide(PLLA) absorbable yarn could be incorporated into the braided, coloredsuture and half-dyed with colorants such as D&C Green #6 or D&C Violet#2. Although neither of these colorants is listed for polypropylene orPLLA suture materials, their safe use in absorbable sutures like PGAwhere all the contained dye is released is a consideration for their usein other suture materials. Thus, the invention described herein cannotbe limited to the current inventory of approved suture materials andlisted color colorants, but can be put to practice with newly listedcolorants, and approved suture materials.

In addition to substituting one end of a continuous colored fiber andone end of a colorless, but dyeable end into a standard braidedconstruction, this invention can also be put into practice by firstco-plying small monofilaments or low denier multifilament of both thesecond and third component materials into the UHMWPE multifilamentbraiding bobbins. This optional method is particularly suited for suturesizes that use small carrier braiding machines where the substitution ofa lower strength colored material for a high strength material mightaffect the overall performance properties of the braided suture. Forexample, a USP size 5-0 high strength suture is braided on a threecarrier braider. If one end of the braid is substituted with an end withcontinuous color and another end with a colorless, but dyeable fiber,then about 67% of the high strength fiber will be lost. This situationis remedied by co-plying the second and third components of theinvention into the braider bobbins of the UHMWPE yarn. When thisconstruction is half dyed, it will contain the benefits of thisinvention. Although this option is directed at braids that contain asmall number of ends, it can certainly be used in all sized sutureconstructions. However, the amount of tensile strength reductionobserved when replacing a high strength UHMWPE end with a lower strengthend is always less than expected as the replacement ends appear tocushion or insulate the UHMWPE ends from each other which leads tohigher retained tensile strength from the remaining UHMWPE ends.

Since the invention is directed at improvements in the cover or outersheath of the suture, this invention is applicable to both corelesssutures and sutures with cores. The cores can be of any constructionincluding twisted or non-twisted multifilament, braided cores ormonofilament cores. However, for most sizes of UHMWPE braided suture acoreless construction is preferred. This is because a corelessconstruction gives better knotting properties for sutures made from highmodulus UHMWPE yarn. For other suture materials a core is normallyneeded to prevent the sheath from collapsing in suture sizes greaterthan about USP size 5-0 to a flat profile which is not optimum forsuturing. The extremely high fiber modulus of UHMWPE of over 75 GPa isprobably the main factor that keeps it from flattening during itshandling, as opposed to the fiber modulus of about 3-10 GPa in othersynthetic braided fibers. The coreless UHMWPE braid will flatten when itcompressed by the forces knotting. This phenomenon contributes to itslower knot profile and improved knotting properties.

In the course of the experiments for this invention is has also beenrecognized that certain dyeing conditions of dye concentration, addedacid concentrations, temperature and time of dyeing can sometimes yieldUHMWPE fiber which contains some degree of shadowing or surfacemodification. In some cases, it appears the normal bright finish of theUHMWPE has been diminished. Accordingly it may be possible to alsoreduce the “glare” of the non-colored UHMWPE sutures by a surfacemodification technique. It is well known that the surface ofpolyethylene can be modified by chemical treatment, photochemicaltreatment, surface grafting, surface oxidation, halogenation, plasma,halogenation or corona treatment. The addition of shadowing to theUHMWPE surface appears to enhance the differentiation provided by thehalf dyed end of the suture of this invention. Thus, shadowing of fibersused in suture constructions may be an important property fordistinguishing sutures.

The half dyeing process can be carried out by a number of differentprocess methods. One of the preferred methods is to wind the suture on aframe and then dip half of it into a dye bath. Of course, the frames canbe of a variety of sizes and configurations including flat, square,rectangular or round. For some sutures that dyeing could also take placeon other devices or even in a skein form. The half dyeing process canalso be carried out on pre-cut pieces of suture that are then half dyedin bundles of the sutures. Certainly other aids to enhance the dyeingprocess can be envisioned. For example, it has also been discovered thatthe junction between the half dyed end and the other end can also beimproved by applying anti-wicking compounds like silicone fluids to thejunction line before the dye dipping process.

The colored sutures of this invention can also be made by performing thehalf dyeing before the braiding process. In this method the colorless,but dyeable fiber is half dyed on a skein or a frame, and thentransferred to a braider bobbin. The suture of this invention can thenbe made by braiding all three end types together on the braider. Noadditional dyeing step is necessary in this method. The procedures formixing and using dye baths for the half and half process will generallyfollow those known to practitioners of the art. For example, in thegreen half dyeing an aqueous solution is prepared of D&C Green No. 5 ata concentration of about 0.02 to 0.2% by weight with an addedconcentration of about 2 to 10% of acetic acid. The dye bath is heatedand half of the suture is dipped into the dye bath for a time period ofabout 5 to 120 minutes. The suture is rinsed of the excess dye, washedand dried for further processing.

It is also important to note that the palate of colors available tocolor sutures is strictly controlled, because sutures are an implantabledevice. Use of any unauthorized colorant is considered adulteration bythe Color Division of the FDA. Colors for particular polymers must belisted in the Code of Federal Regulations (CFR). Therefore, colors orcolor combinations in sutures are extremely limited by FDA regulationsand not by technology available to color polymers or fibers that areused to construct suture products.

Colorants available to provide color to polymers, fibers or braidedyarns must be listed by the FDA and can be classified as either dyes orpigments. Pigments are not soluble in any solvents and must becompounded into the base polymer resin before it is extruded into eithermultifilament or monofilament yarn. Pigments can also be suspended ingel-like solutions to color gel spun fibers. Dyes can also be compoundedinto polymer resins or added to a molten polymer at the end of apolymerization. However, because dyes have solubility in solvent, theycan be used to “solvent dye” fibers or braided yarns used to makesutures. Of course, this method is limited by the ability of the fiberto accept a particular dye. Higher crystalline polymer fibers like thoseof polypropylene or UHMWPE cannot be solvent dyed by normal methods. TheFDA names certifiable dyes as either “FD&C” for solubility in water or“D&C” for solubility in organic solvents. Some D&C dyes, like D&C Green# 5, do have limited amounts of solubility in water and can be used todye fibers in aqueous solutions.

Table 1, below, lists examples of colorants for use in coloring thesutures.

TABLE 1 SUTURE COLORANT Solvent MAX. WT % MATERIAL COLORANT TYPE DyePERMITTED Polyethylene Cr—Co—Al Oxide pigment NO 2.0 Polypropylene[Phthalocyaninato(2-)] pigment NO 0.5 copper Polyester (PET) D&C Green#6 dye YES 0.75 Polyester (PET) D&C Blue #6 dye YES 0.2 Nylon 66, Nylon6 D&C Green #5 dye YES 0.6 Nylon 66, Nylon 6 Logwood Extract dye YES 1.0Nylon 66, Nylon 6 FD&C Blue #2 dye YES 1.0 Silk Logwood Extract dye YES1.0 PGA D&C Green #6 dye NO 0.1 PGA D&C Violet #2 dye NO 0.2 PGA-TMC D&CGreen #6 dye NO 0.21 PGA-PLA (90:10) D&C Violet #2 dye NO 0.2 PLLA NoneNA YES NA PDO D&C Violet #2 dye NO 0.3 PDO D&C Blue #6 dye NO 0.5

Table 2, below, includes examples of various embodiments, for a USP size2 suture having fourteen ends of 110 dtex UHMWPE yarn, of possible colorcombinations for non-absorbable and absorbable co-braids. However, somecolorants included in this chart are not yet approved by the FDA for usein the polymers listed.

TABLE 2 Continuous 6-0 Dyeable Example # Fiber Type Fiber Type Half DyeColor 1 BLUE PP 1E-MONO CLR NYL 1E-MONO GRN NYL 2 BLK NYL 1E-MONO CLRNYL 1E-MONO GRN NYL 3 GRN NYL 1E-MONO CLR NYL 1E-MONO GRN NYL 4 BLUE UPE1E-MULTI CLR NYL 1E-MONO GRN NYL 5 BLUE PE 1E-MONO CLR NYL 1E-MONO GRNNYL 6 BLK NYL 1E-MONO CLR NYL 1E-MONO BLUE NYL 7 GRN PGA 1E-MULTI UNDPLA 1E-MULTI VIOL PLA 8 BLUE PDO 1E-MONO UND PLA 1E-MULTI VIOL PLA 9VIOL PDO 1E-MONO UND PLA 1E-MULTI GRN PLA 10 GRN PGT 1E-MONO UND PLA1E-MULTI VIOL PLA 11 VIOL PGA 1E-MULTI UND PLA 1E-MULTI GRN PLA 12 GRNPGA 1E-MULTI UND PLA 1E-MULTI VIOL PLA

Additionally, Table 3, below, details examples of braided, coloredsutures in accordance with various embodiments of the present invention.The configurations in Table 3 are a subset of possible combinationsdescribed more fully in Table 5.

TABLE 3 Material configuration (UHMWPE w/CLR NYL & BLU PP) UHMWPE YarnCLR NYL BLU PP Lot # Size dtex # of ends size # of ends size # of endsPattern Example R-452 5 440 6 5-0 1 5-0 1 Crossed X X X X X X X R-453 5440 6 5-0 1 5-0 1 In-line / / / / / / / / / / R-454 3/4 220 10 6-0 1 6-01 Crossed X X X X X X X R-455 3/4 220 10 6-0 1 6-0 1 In-line / / / / / // / / / R-456 2 110 14 6-0 1 6-0 1 Standard // // // // // R-457 2 11014 6-0 1 6-0 1 Crossed X X X X X X X R-458 2 110 14 6-0 1 6-0 1 In-line/ / / / / / / / / / R-459 1 110 10 6-0 1 6-0 1 Crossed X X X X X X XR-460 1 110 10 6-0 1 6-0 1 In-line / / / / / / / / / / R-461 0 110 6 6-01 6-0 1 Crossed X X X X X X X R-462 0 110 6 6-0 1 6-0 1 In-line / / / // / / / / / R-463 2-0 55 10 7-0 1 7-0 1 Crossed X X X X X X X R-464 2-055 10 7-0 1 7-0 1 In-line / / / / / / / / / / R-465 3-0 55 6 7-0 1 7-0 1Crossed X X X X X X X R-466 3-0 55 6 7-0 1 7-0 1 In-line / / / / / / / // /

Table 4, below, includes a key to the abbreviations used in Tables 1, 2,and 3. Given the number of suture materials and colorants availablethere are many other combinations possible.

TABLE 4 BLUE PP: Polypropylene monofilament with [phthalocyaninato(2-)]copper colorant. VIOL PP: Polypropylene monofilament with D&C Violet #2colorant. GRN PP: Polypropylene monofilament with D&C Green #6 colorant.CLR NYL: Clear nylon monofilament. BLK NYL: Nylon monofilament withlogwood extract colorant. GRN NYL: Nylon monofilament with D&C Green #5colorant. BLUE NYL: Nylon monofilament with FD&C Blue #2 colorant. BLUEUPE: Blue UHMWPE multifilament with chromium-cobalt-aluminum oxidecolorant. BLUE PE Blue high density polyethylene (HDPE) monofilamentwith chromium-cobalt- aluminum oxide colorant. UND PLA: Undyedpoly-L-lactic acid (PLLA) multifilament. VIOL PLA: Poly-L-lactic acid(PLLA) multifilament with D&C Violet #2 colorant. GRN PLA Poly-L-lacticacid (PLLA) multifilament with D&C Green #6 colorant. BLUE PDO:Polydioxanone monofilament with D&C Blue #6 colorant. VIOL PDO:Polydioxanone monofilament with D&C Violet #2 colorant. GRN PGT:Polyglycolic acid-trimethylene carbonate copolymer monofilament with D&CGreen #6 colorant. GRN PGA: Polyglycolic acid multifilament with D&CGreen #6 colorant. VIOL PGA: Polyglycolic acid multifilament with D&CViolet #2 colorant.

Table 5, below provides additional details regarding another type ofbraid construction for sutures in accordance with various embodiments ofthe invention. Table 5 does not list the possible arrangements of thedifferent fibers on bobbins to be set up on a braider machine that willgive corresponding different arrangements of non-colored and coloredfiber in the produced suture products, some of which by example werepresented in Table 3. Additionally, there are numerous additionalarrangements of non-colored and colored fibers that are possible, andthe examples contained in Table 5 are not meant to limit the inventionin any way. In Table 5, the “CLR Nylon size/dtex” refers to the at leastone third end” of a dyeable fiber. The “colored size/dtex” refers to the“at least one second end” of a continuous colored fiber. The “size”listed for use in the dyeable and continuous fibers is an estimate ofthe size of the ends based upon USP diameter ranges needed to braid thesuture of the invention. However, dependent on other factors, such ashandling properties or surgeon's preferences, either larger or smallerends can be used in braiding.

TABLE 5 UHMWPE Max # Ends Max # Ends Yarn CLR Nylon size//dtex coloredsize/dtex USP Total UHMWPE clear/colored # of # of # of Size # Ends = NN − 2 N/2 dtex ends size dtex ends size dtex ends 5 8 6 4 440 6 5-0110-220  1 5-0 110-220  1 5 8 6 4 440 5 5-0 110-220  2 5-0 110-220  1 58 6 4 440 4 5-0 110-220  3 5-0 110-220  1 3/4 12 10 6 220 10 6-0 55-1101 6-0 55-110 1 3/4 12 10 6 220 9 6-0 55-110 2 6-0 55-110 1 3/4 12 10 6220 8 6-0 55-110 3 6-0 55-110 1 3/4 12 10 6 220 7 6-0 55-110 4 6-055-110 1 3/4 12 10 6 220 6 6-0 55-110 5 6-0 55-110 1 2 16 14 8 110 146-0 55-110 1 6-0 55-110 1 2 16 14 8 110 13 6-0 55-110 2 6-0 55-110 1 216 14 8 110 12 6-0 55-110 3 6-0 55-110 1 2 16 14 8 110 11 6-0 55-110 46-0 55-110 1 2 16 14 8 110 10 6-0 55-110 5 6-0 55-110 1 2 16 14 8 110 96-0 55-110 6 6-0 55-110 1 2 16 14 8 110 8 6-0 55-110 7 6-0 55-110 1 1 1210 6 110 10 6-0 55-110 1 6-0 55-110 1 1 12 10 6 110 9 6-0 55-110 2 6-055-110 1 1 12 10 6 110 8 6-0 55-110 3 6-0 55-110 1 1 12 10 6 110 7 6-055-110 4 6-0 55-110 1 1 12 10 6 110 6 6-0 55-110 5 6-0 55-110 1 0 8 6 4110 6 6-0 55-110 1 6-0 55-110 1 0 8 6 4 110 5 6-0 55-110 2 6-0 55-110 10 8 6 4 110 4 6-0 55-110 3 6-0 55-110 1 2-0 12 10 6 55 10 7-0 20-55  17-0 20-55  1 2-0 12 10 6 55 9 7-0 20-55  2 7-0 20-55  1 2-0 12 10 6 55 87-0 20-55  3 7-0 20-55  1 2-0 12 10 6 55 7 7-0 20-55  4 7-0 20-55  1 2-012 10 6 55 6 7-0 20-55  5 7-0 20-55  1 3-0 8 6 4 55 6 7-0 20-55  1 7-020-55  1 3-0 8 6 4 55 5 7-0 20-55  2 7-0 20-55  1 3-0 8 6 4 55 4 7-020-55  3 7-0 20-55  1

In the braid construction detailed in Table 5, the total number of endsis represented by “N.” The maximum number of ends made from ultra-highmolecular weight polyethylene is “N−2,” and the maximum number of endsthat are clear is N/2.

The many features and advantages of the invention are apparent from thedetailed specification, and thus, it is intended by the appended claimsto cover all such features and advantages of the invention which fallwithin the true spirit and scope of the invention. Further, becausenumerous modifications and variations will readily occur to thoseskilled in the art, it is not desired to limit the invention to theexact construction and operation illustrated and described, andaccordingly, all suitable modifications and equivalents may be resortedto falling within the scope of the invention.

1. A suture comprising: an elongate woven braid of fibers comprising:one or more first ends comprising ultra-high molecular weightpolyethylene; at least one second end comprising a colorable materialwherein the second end is a single continuous color; and at least onethird end comprising a dyeable material wherein at least a portion ofthe third end is dyed a continuous color.
 2. The suture of claim 1,wherein the at least one second end comprises one of polypropylenemonofilament, nylon, polyethylene, or polyester.
 3. The suture of claim1, wherein the at least one third end comprises one of nylon orpolyester.
 4. The suture of claim 1, wherein the braid includes a firstcolor pattern on a first portion of the braid and a second color patterndifferent from the first color pattern on a second portion of the braid.5. The suture of claim 1, wherein one half of a length of the elongatewoven braid is dipped into a dye bath to color the at least one thirdend.
 6. The suture of claim 1, wherein the elongate woven braid isdipped into a dye bath to color the third end and to etch or shadow thefirst ends comprising the ultra-high molecular weight polyethylene. 7.The suture of claim 1, wherein a dye used to color the at least onesecond end is a mordant dye.
 8. The suture of claim 1, wherein the dyeused to color the at least one third end is one of an acid, vat, or asolvent dye.
 9. A suture comprising: an elongate braid of woven fiberscomprising: at least a first end comprising ultra-high molecular weightpolyethylene; at least a second end comprising a dyeable materialwherein the second end is a single continuous first color; and at leasta third end comprising a dyeable material wherein at least a firstportion of the third end is dyed a continuous second color.
 10. Thesuture of claim 9, wherein the second color is different from the firstcolor.
 11. The suture of claim 9, wherein a second portion of the thirdend is dyed a continuous third color, different from the second color.12. The suture of claim 11, wherein the braid includes a first colorpattern on a first portion of the braid and a second color patterndifferent from the first color pattern on a second portion of the braid.13. The suture of claim 9, wherein a junction line between the firstportion of the at least one third end and a second portion of the thirdend is distinct due to an application of an anti-wicking compound duringa step in formation of the suture.
 14. The suture of claim 9, whereinthe second end comprises one of polypropylene monofilament, nylon,polyethylene, or polyester.
 15. The suture of claim 9, wherein the thirdend comprises one of nylon or polyester.
 16. The suture of claim 9,wherein one half of a length the elongate woven braid is dipped into adye bath to color the third end.
 17. The suture of claim 9, wherein theelongate woven braid is dipped into a dye bath to color the third endand to etch or shadow the first ends comprising the ultra-high molecularweight polyethylene.
 18. The suture of claim 9, wherein the dye used tocolor the second end is a mordant dye.
 19. The suture of claim 9,wherein the dye used to color the third end is an acid, vat, or solventdye.
 20. A method of manufacture of a suture comprising: braiding anelongate suture from at least a first end of ultra-high molecular weightpolyethylene, at least a second end comprising a dyeable material and atleast a third end comprising a dyeable material; dyeing the second end asingle continuous first color; dyeing at least a first portion of thethird end a continuous second color.
 21. The method of claim 20, whereinthe second and third ends are dyed before braiding.
 22. The method ofclaim 20, wherein the first portion of the third end is dyed after thethird end is braided into the suture.
 23. The method of claim 20,further comprising dyeing a second portion of the third end a thirdcontinuous color.
 24. The method of claim 20, further comprising dippingat least a half of the elongate suture into a dye bath.